ENBREL 25MG SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE

Kraj: Malezja

Język: angielski

Źródło: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Składnik aktywny:

ETANERCEPT (RECOMBINANT HUMAN TUMOR NECROSIS

Dostępny od:

PFIZER (MALAYSIA) SDN. BHD.

INN (International Nazwa):

ETANERCEPT (RECOMBINANT HUMAN TUMOR NECROSIS

Sztuk w opakowaniu:

04Units Units; 4 Units; 4 Units

Wyprodukowano przez:

Pfizer Manufacturing Belgium NV

Ulotka dla pacjenta

Pfizer Confidential
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_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ENBREL SOLUTION FOR INJECTION IN A
PRE-FILLED SYRINGE
Etanercept (25 mg, 50 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Enbrel is used for
2.
How Enbrel works
3.
Before you use Enbrel
4.
How to use Enbrel
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of Enbrel
8.
Product Description
9.
Manufacturer
10.
Product Registration Holder
WHAT ENBREL IS USED FOR
Enbrel is a biological medicine which
is made by living organisms. The
medicine mimics substances
produced by your body.
Enbrel is used to treat:
•
Moderately to severely active
rheumatoid arthritis (RA). It is a
long lasting inflammation of the
joints. Enbrel can be used alone or
with a medicine called
methotrexate.
•
Active polyarticular juvenile
idiopathic arthritis in children aged
2 years and older who have got
inadequate response or not tolerant
to methotrexate. Polyarticular
juvenile idiopathic arthritis is
inflammation of many joints of
unknown cause seen in children.
•
Active psoriatic arthritis. Psoriatic
arthritis is mainly inflammation of
joints associated with a skin disease
called psoriasis which presents as
scales or flakes. Enbrel can be used
alone or with methotrexate.
•
Active axial spondyloarthritis
which includes ankylosing
spondylitis and non-radiographic
axial spondyloarthritis who have
had an inadequate response to
nonsteroidal anti-inflammatory
drugs (NSAIDs). It is a long lasting
inflammation of joints involving
the spine and other joints which
connects it to the hip bone.
•
Moderate to severe plaque psoriasis
in adults or long lasting severe
plaque psoriasis in children 6 years
and older who were not able to
tolerate or have not benefited from
taking other treatments such as
cyclosporine, methotrexate or
psoralen and ultraviolet-A light
(PUVA).
HOW ENBREL WORKS
Enbrel is a human fusion protein that
blocks the activity of another protein
in the body that causes inflammation,
which in turn reduces inflammation
and damage to you

Charakterystyka produktu

Pfizer Confidential
1. NAME OF THE MEDICINAL PRODUCT
ENBREL
®
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_ACTIVE INGREDIENTS, ACTIVE MOIETIES _
Etanercept (INN)
Etanercept is a human tumor necrosis factor receptor (TNFR) p75 Fc
fusion protein produced by
recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian
cell expression system.
Etanercept is a dimer of a chimeric protein genetically engineered by
fusing the extracellular ligand binding
domain of human tumor necrosis factor receptor-2 (TNFR2/p75) to the Fc
domain of human IgG1. The Fc
component of etanercept contains the hinge, CH2 and CH3 regions, but
not the CH1 region of IgG1.
Solubility: Etanercept is soluble in water.
Molecular weight: (apparent) 150 kilodaltons.
_PHYSICAL CHARACTERISTICS _
_Solution for injection in pre-filled syringe _
The solution for injection in the pre-filled syringe is clear to
opalescent, colorless to yellow
or pale brown,
and liquid may contain trace levels of translucent to white amorphous
particles, with a pH of 6.3 ± 0.2.
3. PHARMACEUTICAL FORM
All Enbrel dosage forms are intended for subcutaneous injection.
Solution for injection in pre-filled syringe.
_COMPOSITION AND PHARMACEUTICAL CHARACTERISTICS _
_Solution for injection in pre-filled syringe _
Each pre-filled syringe contains 25 mg or 50 mg of etanercept (active
ingredient).
The excipients in the pre-filled syringe are sucrose, sodium chloride,
L-arginine hydrochloride, sodium
phosphate monobasic dihydrate, sodium phosphate dibasic dihydrate, and
water.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Rheumatoid arthritis _
Treatment of signs and symptoms and inhibiting the progression of
structural damage in patients with
moderately to severely
active rheumatoid
arthritis
(RA). Enbrel can be
used in combination with
methotrexate in patients who do not respond adequately to methotrexate
alone.
_Polyarticular juvenile idiopathic arthritis _
Treatment of active polyarticular juvenile idiopathic arthritis in
children and adolescents from the age of
2 y